Silodosin vs Tamsulosin as MET

Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese

The spontaneous passage rate for ureteral stone less than 1cm causing acute ureteral obstruction is about 50%. Previous Cochrane review has concluded that alpha blocker is likely to increase stone passage rate, reduce time to stone passage, analgesic use and hospitalisations. The European Association of Urology Guideline also recommends giving alpha blockers as Medical Expulsive Therapy to patients with distal ureteric stones >5mm. However there is heterogeneity in different alpha blockers.

Silodosin is a recently introduced selective alpha blocker which has a much higher selectivity for the alpha-1-A receptor (17-fold compared with tamsulosin). From previous animal studies, ureteral contraction is mainly mediated by the alpha-1-A receptor, hence silodosin maybe more effective in increasing stone passage compared with tamsulosin.

Previous studies and meta-analysis has shown superiority of silodosin over tamsulosin on earlier stone passage and less pain. However, there is no data on Chinese population.

The investigators would like to compare the efficacy and side effect profile of Silodosin versus tamsulosin on improving stone passage rate and hence reduce rate of further intervention for stone clearance.

Study Overview

• Status: Recruiting
• Conditions: Stone, Urinary
• Intervention / Treatment: Drug: Tamsulosin; Drug: Silodosin

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: YI CHIU, MBBS(HK); Phone Number: 29901960; Email: cy225@ha.org.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Hong Kong
    • Contact: YI CHIU, MBBS (HK)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Presented with radio-opaque ureteric stone of size 5mm to 10mm on KUB
• Patients who can understand the study protocol and comply with the followup schedule

Exclusion criteria:

• Radiolucent stone
• Paper thin cortex
• Non-functioning kidney
• Renal insufficiency (serum creatinine greater than 1.8 mg/dl or 160umol/dL)
• Concurrent urosepsis
• Current [alpha]-blocker usage, Ca channel blocker, steroid
• Pregnancy
• Age < 18
• History of ureteral stricture
• History of ureteric stone treatment within 2 years
• Allergic reaction to the study medication
• Unable to Consent
• Patient on JJ stent or PCN drainage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tamsulosin; 0.4mg daily for 4 weeks	Drug: Tamsulosin; Cap tamsulosin
Experimental: Silodosin; 8mg daily for 4 weeks	Drug: Silodosin; Cap silodosin for medical expulsion therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)	FU at week 2
Stone free rate	Wet KUB for stone passage & RFT before FU (check 3/7 before the last FU)	FU at week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain control	Use of analgesics and VAS pain scale (0-10)	FU at week 2
Pain control	Use of analgesics and VAS pain scale (0-10)	FU at week 4

Collaborators and Investigators

• Sponsor: Princess Margaret Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Calculi; Urinary Calculi; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Silodosin
• Other Study ID Numbers: KW/FR-19-075-(139-02)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes